Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

Thrombocytopenia Clinical Trial

Official title:

Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263809
• Other study ID #: CTS-0028
• Status: Completed
• Phase: Phase 0
• First received: December 7, 2005
• Last updated: October 6, 2009
• Start date: December 2005
• Est. completion date: October 2007

Study information

• Verified date: October 2009
• Source: Terumo BCTbio
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

Description:

The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male or female of age of 16 years or older

• Women of Child Bearing Potential not pregnant

• Subject must have signed and dated the Informed Consent form

• Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion

Exclusion Criteria:

• History of any hypersensitivity reaction to riboflavin or metabolites

• History of refractoriness to platelet transfusions

• Positive lymphocytotoxic antibody test

• Active bleeding

• Splenomegaly

• Acute or chronic Disseminated Intravascular Coagulation

• History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome

• History or diagnosis of an autoimmune disease affecting haemostasis

• History of solid organ transplants

• Evidence of occlusive venous disease

• Clinical signs of infection at the time of inclusion

• Pregnant or lactating females

• Chronic alcohol misuse

• Use of prohibited medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Intervention

Device:
• Pathogen Reduction Technology

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Jean Minjoz	Besançon
France	EFS Bourgogne - Franche-Comté	Besançon
France	EFS Aquitaine	Bordeaux
France	Centre Hospitalier Univesrsitaire A Michallon	La Tronche
France	EFS Rhône-Alpes (Site de Grenoble)	La Tronche
France	Centre Hospitalier Universitaire Hôtel Dieu	Nantes
France	EFS Pays de la Loire	Nantes
France	Centre Hospitalier Universitaire de Bordeaux	Pessac
France	Centre Hospitalier Régional Universitaire Hautepierre	Strasbourg
France	EFS Alsace	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCTbio

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The platelet corrected count increment measured 1 hour post transfusion.
Secondary	The platelet corrected count increment measured 24 hours post-transfusion.
Secondary	The number of days between platelet transfusions during the period of the study.
Secondary	The number of platelet transfusions per subject.
Secondary	The number of platelets infused per subject.
Secondary	The number of platelets used.
Secondary	The frequency of refractoriness to platelet transfusion.
Secondary	In case of refractoriness, the evidence for neoantigen immunization against test product.
Secondary	The number of red blood cell transfusions during the study period.
Secondary	The incidence of serious adverse events in relation to platelet transfusions.
Secondary	The incidence of any adverse events in relation to platelet transfusions.
Secondary	The occurrence of bleeding episodes.